The following data is part of a premarket notification filed by Jedental Co., Inc. with the FDA for Jedental Psrofill Self-cure Composite.
| Device ID | K933656 |
| 510k Number | K933656 |
| Device Name: | JEDENTAL PSROFILL SELF-CURE COMPOSITE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | JEDENTAL CO., INC. 324 SECOND ST. PIKE Southampton, PA 18966 |
| Contact | John Wong |
| Correspondent | John Wong JEDENTAL CO., INC. 324 SECOND ST. PIKE Southampton, PA 18966 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-27 |
| Decision Date | 1993-11-17 |